Menu
Recruiting NCT07156903

Evaluation of Needs of Patients and Care-givers During and After Radiotherapy of Patients With Prostate Cancer

No phase Interventional Prostate Cancer Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Interview.
Who it may be relevant to
Registry conditions: Prostate Cancer Patients. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Qualitative Erhebung Zur Erfassung Der Bedürfnisse Von Patienten Und Deren Angehörigen während Und Nach Einer Strahlentherapie Bei Prostatakarzinomerkrankung Und Deren Einstellung Und Wünsche bezüglich Einer Prähabilitationsmaßnahme

Overview

Exploratory qualitative survey to assess the needs of patients and their relatives during and after radiotherapy for prostate cancer and their attitudes and wishes regarding prehabilitation measures

Detailed description

Across Germany, more than 500,000 people are newly diagnosed with cancer each year (Center for Cancer Registry Data, RKI, 2020). Prostate cancer, the most common cancer in men, affects more than 65,000 patients annually (https://www.krebsinformationsdienst.de/prostatakrebs). The gold standard for the treatment of advanced prostate cancer is radiotherapy combined with anti-hormonal therapy. If the cancer is detected earlier, surgery can be performed. Both procedures are then considered to be oncologically equivalent. Despite the most modern treatment methods and techniques, severe acute and long-term side effects still occur, which patients can experience as extremely limiting. These include, among other things, loss of libido and erectile function, the development of bladder weakness and even incontinence, and changes in bowel function (e.g., diarrhea).

Currently, patients often only begin treatments designed to mitigate these side effects during their rehabilitation, at least 4-6 weeks after therapy. However, the investigators believe that greater effects can be achieved and even the occurrence of serious side effects can be potentially prevented if treatment is initiated before or during therapy. This concept is called prehabilitation.

In order to develop a suitable prehabilitation program for prostate cancer patients undergoing curative radiation therapy (either definitive or postoperative), the investigators will conduct interviews with patients and, if possible, their immediate family members (e.g., partners) to learn more about their experiences before, during, and after the treatment. The investigators would also like to learn more about their attitudes and wishes regarding prehabilitation measures.

Interventions

  • Other Interview
    Patients and their care-givers will be asked to participate in interviews

Primary outcome measures

  • Qualitative Evaluation of Interviews [Time frame: interviews will take place once either during radiotherapy or during follow up (planned 30 participants each); Each interview is expected to last 60 minutes.]

Eligibility criteria

Inclusion criteria

  • Diagnosed Prostate Cancer with curativ intended Radiotherapy
  • min. 18 years
  • sufficient knowledge of German language for participation in interviews
  • Capacity to consent

Exclusion criteria

  • age <18 years

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

Germany · 1 center
  • Charité Universitätsmedizin Berlin — Berlin

Identifiers

NCT: NCT07156903 · EA4/121/25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗